Age-related macular degeneration (AMD) is the major cause of irreversible legal blindness in the western world. Over 12 million Americans have some type of AMD, with millions of other suffering from other retina issues. Current self-monitoring tools for retina diseases fail to adequately indicate the need for treatment, resulting in delayed treatment starts and higher incidences of severe vision loss. These inventions will boost patients' ability to accurately and confidently self-monitor their vision between office visits resulting in fewer people losing their sight.
The Amsler and Yanuzzi grids, the only widely used self-tests for AMD, have proven largely ineffective at enabling patients to recognize the signs that they should consult their retina specialist for treatment. There are no other commonly available tools for patient self-monitoring in one's home between office visits. The Amsler Grid has been in use and largely unchanged for more than 60 years. Shortcomings of the Amsler grid include but are not limited to: periodicity of the test pattern, lack of individual adjustment, lack of visual & memory stimulating triggers, inability to overcome the visual completion phenomenon, poor compliance, subjectivity, lack of quantification, anxiety and doubt, relatively high levels of concentration required and habituation.
While the dry form of AMD progresses slowly over years, the wet form of AMD progresses rapidly and can mature from a nascent stage to legal blindness in fewer than 12 months. Thus, annual vision check-ups are not sufficient to protect patient's visual health; and accurate self-monitoring is essential. However, the current grid tests do not provide accurate self-monitoring. The result is that many people are needlessly suffering advanced vision loss and blindness because they lack the ability to accurately and confidently monitor their vision and know when to accelerate their visit to their eye care professional before their scheduled appointment date.
There have been great strides in research and treatment over the past 5 years. New treatments such as drug therapy (VEGF treatments such as Macugen® from Eyetech/Pfizer and Lucentis® from Genentech) and photodynamic therapy now add significant mechanisms to the available armamentarium of care. These new treatments, however, are most effective when they treat problems in the early stages. For them to be most effective—there must be a reliable means of detecting problems such as metamorphopsia and onset of new blood vessel growth early. Delay in the start of any retina treatment can greatly limit the eventual outcome. Efficacy of drug treatment declines according to the progression of the disease; too much delay greatly increases the likelihood of vision loss and blindness.
In clinical testing, the Amsler grid has not proven successful at enabling patients to detect issues nor to understand when to seek council of their retina specialist. The following references are made to the scientific literature:
Referencing: Schuchard, Arch. Ophthalm 1993 vol 111 no. 6
“For scotomas of 6 degrees or less in diameter, 77% of standard and 87% of threshold scotomas were not detected by Amsler grid testing.” “Amsler Grid reports have poor validity and cannot be accurately interpreted for use in the clinical diagnosis of retinal defects.”
Zaidi, et al, Eye, May, 2004—
“The surveillance protocol detected less than 30% of the specific patients who subsequently underwent laser treatment.” “Bearing in mind the prevalence of AMD and the increased therapeutic importance of early detection of SRN, it is clear that improvements in the current surveillance protocol are required.”
Achard, et al, Am J. Ophthalmol. 1995—
“Results of two successive Amsler grid tests were not comparable, even when the technique was identical and time between tests was no more than 2 to 15 min.” “the Amsler grid technique is unreliable for evaluating central scotomas.”
A variety of reasons have been put forward by these studies to explain the reasons behind the poor performance of the Amsler grid:
Schuchard, Arch. Ophthalm 1993 vol 111 no. 6
“The perceptual filling-in of patterns such as the Amsler grid and fixation characteristics have a major influence in the result of Amsler grid testing.”
Zaidi, et al, Eye, May, 2004—
“ . . . difficulty with compliance . . . ”, “ . . . problems with the subjective nature of the test.”, “Relatively high levels of concentration are needed to undertake the test . . . ”, “ . . . levels of fatigue and anxiety are important,”, “ . . . compounded by the perceptual completion phenomenon . . . ”
Achard, et al, Am J. Ophthalmol. 1995—
“Our data corroborated Schuchard's observations regarding the relatively poor sensitivity of Amsler grid tests.”, “Additionally, our study further characterized the completion phenomenon found when Amsler grid tests are used and emphasized the rapid changes that occur in completion over time.”, “It cannot be excluded that the changes in results over time were partly because of changes in fixation position.”
This research is corroborated by the inventor's general conversation with retina patients. In interviews, the following assertions are supported by patient anecdotes:                1. Poor compliance with test protocol—many neglect to do any testing        2. Confusion regarding purpose—many did not know why they were given the Amsler        3. Confusion regarding baseline & monitoring—none knew they were supposed to monitor their vision over time        4. Confusion regarding proper usage—several reported looking for “moving” or “changing” lines as if they expected to see motion on the card as the symptom of further disease        
In the inventor's personal experience as a wet AMD patient for over 10 years, the Amsler grid has shortcomings in further areas, including but not limited to:                1. Difficulty in detecting changes to vision especially subtle changes        2. Difficulty in locating the periphery of the affected, scarred or damaged retinal area        3. Difficulty in detecting changes to the size or complexion of an affected area        4. Difficulty in establishing a benchmark viewing distance        5. Difficulty in locating and/or maintaining a gaze at the center of a grid without wandering        6. Difficulty in remembering the exact limits of an affected area        
The impact of these diagnostic shortcomings include but are not limited to:                1. Substandard identification of newly affected areas (of the retina)        2. Incorrect or missing identification of newly affected areas        3. Substandard assessment of size and complexion of affected areas        4. Lack of confidence in daily measuring        5. Frustration with the assessment process        6. Variation in day-to-day assessment of the overall size and complexion of an affected area        
The result and consequences of these impacts include but are not limited to:                1. Unnecessary delays in reporting to retina specialists resulting from lack of confidence in one's self assessment of visual loss (ie: patients fail to present because of internal doubt that could be personified by the following fictional self-talk dialogue: “Am I sure that my vision was truly different last week, who am I to make such a diagnosis?”)        2. Missed detection of problems at their onset        3. Delays of days/weeks/months/years before problems are identified (either because the problem is finally impacting routine daily visual activities or problem is finally identified by a healthcare professional)        4. Unnecessary delay in start of treatment (delay in presenting promptly delays start of treatment) thereby diminishing the likelihood of optimum treatment effectiveness        5. Unnecessary sense of anxiety & frustration resulting from not knowing the status of one's eye health between office visits (ie: am I losing my vision?)        6. Emotional consequence of feeling helpless and unable to participate in disease management        7. Poor compliance with regular monitoring of existing problems        8. Higher likelihood of vision loss        
The implication to the drug industry are many:                1. Fewer patients receive treatment at the earliest stages of disease        2. Fewer patients fall within the treatable range of the disease because many have progressed beyond acceptable treatable limits        3. More patients fail to receive full benefit of their treatment, some find the treatment ineffective because they started late, and many lose significant vision        4. The drug and class of drugs does not get as good of a reputation if compared to a scenario where all patients reported onset days or weeks earlier        5. Sales of drugs suffer        6. Marketing budgets may need to be increased to compensate for lack of “word of mouth”        
Societal implications include, but are not limited to:                1. Vision loss directly reduces a patient's ability to be a productive contributor to society        2. Vision loss indirectly taps patient's family's ability to productively contribute to society        3. Vision loss increases the need for social services and other governmental support        4. Delayed presentation increases the extent of drug/PDT/laser treatment required, increasing the monetary costs through public & private insurance programs        
I feel strongly that the novel ideas and approaches enclosed will benefit others by giving them more accuracy, simplicity and ease in the monitoring of their vision. As a result, monitoring will be performed more regularly, with better adherence and higher accuracy and confidence. And thus, any necessary treatments will be delivered as soon as practical thereby increasing the chances for best treatment results and reducing the risk of vision loss and blindness.
Definitions:
By the term “affected area”—I mean to describe any type of disturbance to the retina—whether the result of dry macular degeneration, wet macular degeneration, diabetic retinopathy, toxic histoplasmosis, scarring from light or laser, blind spots (scotomas), etc. These words will be used to describe the disturbance in any phase of progression from onset through maturity, pre and post treatment.
I will use the terms “person”, “patient”, “user” and “people” all interchangeably. It is not my intent to limit the inventions by narrowing their use to any particular population. These inventions are valuable to all people in any state of health or with any type of eye disorder (save total blindness).
By the term “grid test”—I mean tests such as the Amsler test that are commonly known in the ophthalmology field for detecting the presence of retina disturbances, detecting the size and shape of the affected part of a patients visual disturbance, and through a protocol of monitoring over time, detecting changes to the size and/or shape of the affected area.
By the term “visually stimulating grid”—I mean a grid test that has sufficient differentiation in the qualities of the lines within the grid to enable a patient to recall (verbally or through manually pointing) the difference between one line and the neighboring parallel line (which stands in contrast to traditional grid tests which have ostensibly identical lines that are difficult to differentiate and thus difficult to recall).
By the term “plurality of distinguishably different lines”—I mean that at least four or more lines within the grid are differentiated from the other lines in the grid through the use of color, dash or dot line patterns, line weight (aka: stroke or boldness), double lining (aka: very proximate parallel lines), or a combination of these approaches.
By the term “orientation of the distinguishably different lines”—I mean that the plurality of distinguishably different lines are organized in the grid in a way that is perceived by users to be a pattern and not as a discordant or chaotic layout, which implies a the layout to be congruous with any commonly understood visual pattern, such as symmetry, concentricity, progression, among others.
By the term “indicia”—I mean the use of letters & numbers to represent the pattern of lines within a grid test, one embodiment of which would be latitude & longitude markings of “Up 1”, “Up 2”, etc.
By the term “illuminance threshold”—I mean the point at which a grid test's surface illuminance stands in proper differentiation to the illuminance of the surrounding area so that a patient's affected area appears more pronounced because the “filling-in phenomenon” is partially over-ridden.
By the term “outer limit perimeter line”—I mean a line that is created immediately beyond the limits of a patient's affected visual area, and thereby establishes a surrogate manner of measuring the size & shape of a patient's affected visual area at a given moment in time.
By the term “results of the size and shape of the outer limit perimeter line test”—I mean both the quantifiable measurements of perimeter geometry (such as height×width and an anchor location in the x/y plane) as well as well as the qualitative memory of the size and shape of a patient's affected area.
By the term “pairing of at least two parallel lines”—I mean that lines can be intentionally drawn parallel to each other and separated by a space equal to 1× to 8× the stroke width of the line.
By the term “surface area outside of the perimeter”—I mean the surface area of a grid test that lies outside the surface area of the shape that defines the perimeter.
By the term “poor compliance”—I mean a patient's failure to use a test on a regular basis over days, weeks and months which leads to an inability to track vision loss over time.
By the term “subjectivity of the test”—I mean a lack of ability within the test that would enable consistent measurements over weeks and months of usage.
By the term “lack of quantification”—I mean the lack of patients' ability to remember the extent and shape of a visual distortion or scotoma at a given time.
By the term “anxiety”—I mean that patients who are experiencing visual challenges are under emotional strain and the lack of consistent self-monitoring measurements can exacerbate this state of emotional unrest, and especially a heightened fear of impending blindness.
By the term “doubt”—I mean that patients who are unable to have confidence in the measurement of their vision often don't know whether to attribute a change in their vision to a progression of their disease or consider it within the limits of their test.
By the term “relatively high levels of concentration required”—I mean the lack of proper visual and memory stimulus in Amsler grids places high demands on the patient to maintain concentration.
By the term “habituation”—I mean that patients using the Amsler grid “get used” to seeing distortions and reduces ability to detect and differentiate changes over longer time intervals.
I will use the words “changes to vision”, “metamorphopsia”, and “changes to affected area” very loosely and often interchangeably.
I will use the terms “earliest stages of disease” and “onset of issues” very loosely and often interchangeably. I will use the terms “adherence”, “compliance and “persistence” very loosely and often interchangeably. These terms are used thusly because a general usage does not have a material impact on the nature of the inventions.
By the term “Visual completion phenomenon” (aka the “filling in phenomena”)—I mean that the brain working together with the eyes is able to fill-in and approximate areas of missing vision and thus makes proper visualization of the size and shape of an affected area of the visual field (such as a scotoma) difficult, less accurate and less able to track over months & years of time
Expanding Upon the “Visual Completion Phenomenon”:
As we know from clinical research and personal experience, vision is based on the brain's interpretation of visual data from the eyes. Thus, “vision” is comprised of both an “optical-sensory”component and a “cognitive” component. Metaphorically speaking: V (vision)=OS (optical sensory)+C (cognitive). Tests of acuity and grid reading, therefore, reflect both the patient's optical-sensory performance and cognitive abilities.
In measuring the progression of macular degeneration and other retinal illnesses, our prime concern is on the condition and health of the optical-sensory components of vision and their ability to perform. Measuring their performance, however, must be done in recognition that the cognitive process is not a constant. Metaphorically speaking: OS (optical sensory)=V (vision)−C (cognitive).
Especially in cases of eye disease, the cognitive process is boosted into a highly active state to help compensate for the optical-sensory deficiencies. This being the case, we must understand ways to over-ride the cognitive manipulation of optical sensory data or to normalize the cognitive manipulation during times of measurement to a constant value.
Whether we know it or not, each of us has two blind spots (aka “affected areas”) in our vision. The optic nerve passes through each of our retinas, creating small areas devoid of rods and cones. This results in an actual blind spot in each of our eyes. However, because of the cognitive process, the great majority of people will go through life and never know that they have these “holes” in their vision
Why? Because the brain takes the visual data surrounding the affected area and then “fills in the hole” with what it considers to be the best match. The same thing happens with retinal scars or affected areas.
So, if you are looking at a yellow wall, the brain instantly “fills in” the affected area with the same yellow color. If you are looking at a black wall, the brain instantly “fills in” the affected area with the same black color. And amazingly, if you are looking at a pattern, the brain continues the pattern over the affected area. This applies to the grid tests as well, and complicates the measuring of affected areas.
Impact of the “Filling-In Phenomenon”:
Grid tests are based on the assumption that scarred or damaged areas will show up as “holes” or wavy lines on the grid. Unfortunately, the cognitive process extrapolates the grid and attempts to fill in the hole by continuing the grid pattern in the affected area—especially around the edges. This makes these tests frustrating and reduces their accuracy.
Thus, grids are all limited in their ability to function based upon their inability to differentiate what part of the perceived image is due to the cognitive process and what part of the perceived image is due to the optical sensory visual output of the eyes.
Over-Riding the Cognitive Process to Help Improve Measurement:
While the brain attempts to compensate for 100% of the affected area, it has its limitations. By exceeding these limitations, we can isolate the effects of the cognitive process and better measure the sensory-visual performance.
From my experience, the brain is limited in three major areas in its ability to “fill-in” an affected area:                1. Non-continuous patterns        2. Very bright objects or surfaces        3. Discontinuously dynamic objects (moving, flashing, color shifting or changing in a meaningful way)        
By employing some/all of these into a testing protocol, we are able to help the user understand when their vision is being impacted by the filling-in phenomenon.